U.S. patent number 6,998,510 [Application Number 10/358,881] was granted by the patent office on 2006-02-14 for method and apparatus for improved hemostasis and damage control operations.
This patent grant is currently assigned to Damage Control Surgical Technologies, Inc.. Invention is credited to Robert F. Buckman, Jay A. Lenker.
United States Patent |
6,998,510 |
Buckman , et al. |
February 14, 2006 |
Method and apparatus for improved hemostasis and damage control
operations
Abstract
Devices and methods are disclosed for achieving hemostasis in
traumatized patients. The devices utilize fluid impermeable outer
surfaces and distributed pressure to achieve tamponade and
hemostasis, primarily by exertion of pressure. The devices are
capable of serving as carriers for throabogenic or antipathogenic
agents. Peripheral haemostatic packing devices include optional
adhesive hemostatic barriers to cover the entire wound area over
the hemostatic pack. The hemostatic packing devices may be placed
and removed by open surgery or laparoscopic access without
generating excessive re-bleeding, and may further comprise
antimicrobial or thrombogenic regions.
Inventors: |
Buckman; Robert F. (Radnor,
PA), Lenker; Jay A. (Laguna Beach, CA) |
Assignee: |
Damage Control Surgical
Technologies, Inc. (Laguna Beach, CA)
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Family
ID: |
27737457 |
Appl.
No.: |
10/358,881 |
Filed: |
February 4, 2003 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20030176828 A1 |
Sep 18, 2003 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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60424038 |
Nov 5, 2002 |
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60354429 |
Feb 4, 2002 |
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Current U.S.
Class: |
602/48; 424/443;
604/358 |
Current CPC
Class: |
A61F
13/00063 (20130101); A61F 2013/00468 (20130101); A61F
2013/00472 (20130101); A61F 2013/00565 (20130101); A61F
2013/0074 (20130101); A61F 2013/0091 (20130101) |
Current International
Class: |
A61F
13/00 (20060101); A61F 13/15 (20060101) |
Field of
Search: |
;602/41-43,48
;604/358,304-308,1,11 ;424/443-449 ;428/48 ;528/386,385 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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WO 00/25726 |
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May 2000 |
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WO |
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WO 2004062704 |
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Jul 2004 |
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WO |
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WO 2004080498 |
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Sep 2004 |
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WO |
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Primary Examiner: Lewis; Kim M.
Attorney, Agent or Firm: Crockett & Crockett Crockett,
Esq.; K. David
Parent Case Text
The present application claims priority benefit under 35 USC .sctn.
119(e) from U.S. Provisional Application No. 60/354,429 filed Feb.
4, 2002, entitled "METHOD AND APPARATUS FOR IMPROVED HEMOSTASIS AND
DAMAGE CONTROL OPERATIONS" and U.S. Provisional Application No.
60/424,038 filed Nov. 5, 2002, entitled METHOD AND APPARATUS FOR
EMERGENCY VESSEL ANASTOMOSES, both of which are herein incorporated
by reference.
Claims
What is claimed is:
1. A device adapted for packing a wound and achieving hemostasis
comprising: a three dimensional pack, said pack comprising a soft,
pliable substrate at least partially covered with a fluid
impermeable covering; a releasable attachment means adapted for
releasably securing the pack to other packs; and anti-pathogenic
agents disposed on the covering.
2. A device adapted for packing a wound and achieving hemostasis
comprising: a three dimensional pack said pack comprising a soft,
pliable substrate at least partially covered with a fluid
impermeable covering; a releasable attachment means adapted for
releasably securing the pack to other packs; and haemostatic agents
disposed on the covering.
3. A device adapted for packing a wound and achieving hemostasis
comprising: a three dimensional pack, said pack comprising a soft,
pliable substrate at least partially covered with a fluid
impermeable covering; a releasable attachment means adapted for
releasably securing the pack to other packs; and a plurality of
indentations filled with haemostatic agents.
4. A device adapted for packing a wound and achieving hemostasis
comprising: a three dimensional pack, said pack comprising a soft,
pliable substrate at least partially covered with a fluid
impermeable covering; a releasable attachment means adapted for
releasably securing the pack to other packs; and a plurality of
indentations filled with anti-pathogenic agents.
5. The device of claim 1, 2, 3, or 4 wherein the device substrate
comprises a water swellable hydrogel and a fluid permeable region
on at least a portion of said outer surface of said device.
6. The device of claim 1, 2, 3, or 4 wherein the substrate
comprises cotton gauze.
7. The device of claim 1, 2, 3, or 4 wherein said substrate
comprises foam.
8. The device of claim 7 wherein said foam comprises polyurethane,
polyvinyl chloride, polyethylene, polyvinyl acetate, silicone
rubber, polyvinyl chloride, polymethyl methacrylate or a copolymer
including one of these materials.
9. The device of claim 1, 2, 3, or 4 wherein said substrate
comprises open-cell foam.
10. The device of claim 1, 2, 3, or 4 wherein said substrate
comprises closed-cell foam.
11. The device of claim 1, 2, 3, or 4 wherein said substrate
comprises silicone oil.
Description
FIELD OF THE INVENTION
The field of this invention is wound care during trauma surgery,
general surgery, combat medicine, and emergency medical
services.
BACKGROUND OF THE INVENTION
As recently as the early 1990s, surgical operations for trauma were
directed at the anatomic repair of all injuries at time of the
initial operation. It was observed during these exercises that many
patients became hypothermic, acidotic, and coagulopathic. Patients
showing these three signs often died. Death often occurred in the
operating room due to exsanguinations, or postoperatively, due to
the complications of prolonged shock and massive transfusion to
replace blood lost as a result of the trauma.
One of the most notable developments in the recent evolution of
surgery has been the introduction of the concept of staged
laparotomy to overcome the deficiencies of the repair all-at-once
approach. This new strategy of staged laparotomy, employing new
tactics that have been termed damage control, is now used in 10% to
20% of all trauma laparotomies.
Ever since the advent of abdominal surgery, surgeons have relied on
the same thinly woven cotton gauze packing pads that are currently
in favor. These gauze pads are called laparotomy pads or Mickulitz
pads. These pads were designed for use as sponges but not for use
as hemostatic tampons. Nonetheless, since World War I, surgeons
faced with severe bleeding have relied on packing patients with
these sterilizable gauze sponges in an effort to control bleeding.
Since World War II, it has been known that abdominal packing using
these pads has been associated with abdominal sepsis and
re-bleeding after pad removal. Despite these limitations, even
today, they are the mainstay of damage control hemostasis.
The specific issues with the gauze pads are that they are porous
and allow the free passage of blood through the mesh. Other
unfavorable characteristics include the lack of intrinsic
coagulation inducing properties. The pads are easily saturated but
these pads do not stick to one another. The pads are capable of
promoting infection because they serve as a nidus for bacteria in a
contaminated field. They have no intrinsic antiseptic or
antimicrobial action. These pads are unsuitable for packing solid
viscera because they stick to the visceral wound tissue and cause
re-bleeding upon removal. Although generally recognized as
sub-optimal, the gauze pads have the advantages of being cheap,
familiar and ubiquitous. For these later reasons, they continue to
remain the mainstay of damage control hemostasis. Among the
opportunities for new technologies and instruments to support the
process of damage control, the first requirement is an improvement
in the surgical pack.
Other current pads for hemostasis include gel-foam, Surgicel, and
fibrin sponges. These devices are all liquid permeable and require
blood coagulation to occur before impermeability and hemostasis are
achieved. In addition, the fibrin sponges are very rigid and will
not conform to a wound while in the dry state. Typical examples of
the prior art in hemostatic packing systems include U.S. Pat. No.
5,643,596 to Pruss et al., U.S. Pat. No. 5,763,411 to Edwardson et
al., U.S. Pat. No. 5,800,372 to Bell et al., U.S. Pat. No.
6,054,122 to MacPhee et al., and U.S. Pat. No. 6,056,970 to
Greenawalt et al. These patents, all of which are included herein
by reference, disclose permeable hemostatic packing and dressings
with topical hemostatic coatings. These devices all serve the
purpose of stopping bleeding in underlying vessels with an
occlusive backing but the backing is still permeable to blood
leakage. The lack of impermeability in these prior art patents is
not recognized as an issue.
While hemostatic packing devices are well known in the art, the
utility of said packing devices is limited by their propensity to
harbor pathogens and their propensity to create re-bleeding by
adherence to healing surfaces.
New devices, procedures and methods are needed to support the
strategy of damage control in patients who have experienced massive
bodily injury. Such devices and procedures are particularly
important in the emergency, military, and trauma care setting.
These new devices rely on the principles of impermeability to blood
passage, limited nidus formation for bacteria, the ability to carry
pro-thrombogenic material, and the lack of intrinsic
thrombogenicity except by providing a physical barrier or pressure
source.
SUMMARY OF THE INVENTION
The devices and methods described below provide for improved
hemostatic packing in trauma care. The devices comprise impermeable
barrier packs with various features provided to improved
hemostasis, improved packing and placement of the packs, and easier
removal of the pack after hemostasis is achieved. Other features of
the pack include foldability and moldability to the anatomical
surface. The exterior surface of the pack is not intrinsically
thrombogenic but is capable of serving as a carrier for
thrombogenic substances. Certain regions of the exterior surface of
the pack may optionally comprise thrombogenic properties. The pack
may be made with a plurality of surfaces, each with distinct
characteristics. An exemplary version of the pack has a thin layer
of polyethylene or polypropylene, which is impermeable to liquids,
as its entire outer surface. A key advantage of the present
invention, in its wet or dry state, is moldability, flexibility and
shapability to the anatomical contacting surface, including the
ability to pack wounds in solid viscera. The pack is able to
distribute pressure within the wound to generate pressure
tamponade. The pack is capable of generating pressure tamponade
without regions of sharp or high stress such as would be generated
by a rigid packing system. This improvement over certain very hard
packing devices allows for better fit to the anatomy and the
immediate formation of an impermeable barrier without the need to
wait for blood coagulation to occur to form the hemostatic barrier.
The hemostatic pack of the present invention is placed via open
surgery or through laparoscopic instrumentation. The laparoscopic
embodiment includes the capability of reversibly or irreversibly
achieving a size and mass change in the device once it is placed
within the patient.
The present invention distinguishes over the cited prior art
because it requires no thrombogenic coatings, although it is
capable of trapping and carrying such pro-thrombogenic coatings on
its surface. The outer surface of the haemostatic packing sponge
serves as a carrier by incorporating indents or villi to physically
hold the pharmacological, thrombogenic or antibacterial coatings.
Since the surface is impermeable to liquids, the arrest of
hemorrhage is immediate and does not require thrombosis to occur.
When the packing device of the present invention is removed from
the patient, re-bleeding does not occur because there is no
penetration of the wound tissues or clot into the interstices of
the pack. An additional advantage of the impermeable pack is a
resistance to bacteria and other pathogenic penetration.
In another embodiment of the invention, the pack comprises raised
ridges or dams on its surface. These ridges or dams are comprised
of soft conformable materials that form an edge seal to prevent the
escape of blood from a wound. The pack optionally comprises
additional regions or borders of enhanced blood clotting or
thrombogenesis to assist with the hemostatic properties of the
device.
In yet another embodiment of the present invention, the hemostatic
pack comprises adhesives, fasteners, or the like to allow the packs
to adhere to each other, thus forming a syncytium, or contiguous
barrier comprised of more than one component, to prevent blood from
escaping from a wound.
For purposes of summarizing the invention, certain aspects,
advantages and novel features of the invention are described
herein. It is to be understood that not necessarily all such
advantages may be achieved in accordance with any particular
embodiment of the invention. Thus, for example, those skilled in
the art will recognize that the invention may be embodied or
carried out in a manner that achieves one advantage or group of
advantages as taught herein without necessarily achieving other
advantages as may be taught or suggested herein.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1A illustrates a two-sided hemostatic pack comprising a sheet
of material that is impermeable to liquid on one side and the other
side is a permeable fabric affixed to the impermeable barrier;
FIG. 1B illustrates a cross-sectional view of the two-sided
haemostatic pack;
FIG. 1C illustrates the two-sided hemostatic packing device folded
with the impermeable surface facing outward toward the wound
surface;
FIG. 1D illustrates the two-sided hemostatic pack rolled with the
impermeable side out;
FIG. 2 illustrates a hemostatic packing device comprising a
closed-cell foam that is impermeable on both sides;
FIG. 3 illustrates a hemostatic packing device comprising an outer
surface that is impermeable on both sides where the upper surface
further comprises indentations capable of carrying exogenous
thrombogenic substances;
FIG. 4 illustrates a hemostatic packing device comprising a
polygonal deformable solid with an impermeable outer surface;
FIG. 5A illustrates an inflatable hemostatic packing device;
FIG. 5B illustrates one embodiment of the inflatable hemostatic
packing device in its deflated or partially deflated state;
FIG. 6 illustrates a hemostatic packing device being introduced
into a patient through a laparoscopic instrument;
FIG. 7 illustrates a hemostatic packing device comprising an
adhesive on at least a portion of the outer impermeable surface of
said hemostatic packing device;
FIG. 8 illustrates a hemostatic packing device comprising a packing
material with an impermeable outer surface affixed to an adhesive
impermeable drape;
FIG. 9A illustrates a wound of the liver;
FIG. 9B illustrates the wound of the liver being treated by
application of internal tamponade of hemorrhage with the
impermeable hemostatic packing device used in a peri-hepatic
location;
FIG. 10A illustrates a wound of an exemplary extremity, the thigh,
with femoral artery transection;
FIG. 10B illustrates the wound to the thigh being treated by
application of an impermeable hemostatic packing device with the
adhesive impermeable drape;
FIG. 11 illustrates a wound dressing or bandage comprising a blood
dam, for treating a wound to the arm or the leg.
FIG. 12 illustrates a wound dressing or bandage for treating a
wound to the arm or the leg comprising a series of blood dams.
FIG. 13 illustrates a wound dressing or bandage for treating a
wound to the arm or the leg comprising a blood dam with a
communicating valve;
FIG. 14A illustrates a lateral sectional view of two internal
hemostatic packs for solid organs, viscera, and the like;
FIG. 14B illustrates a lateral sectional view of two internal
hemostatic packs that have been joined together to form a syncytium
wherein the barrier regions or dams render the adherent region
impermeable to fluids such as blood.
FIG. 15 illustrates an oblique view of a preferred wound dressing
or bandage for treating a wound to a body part comprising a strap,
a blood dam, and a pillow pack.
DETAILED DESCRIPTION OF THE INVENTION
FIG. 1A illustrates a diagram of a two-sided hemostatic packing
device 10 of the present invention. The two-sided packing device 10
comprises a blood permeable layer or substrate 12 and a fluid
impermeable covering 14. The fluid impermeable sheet 14 further
comprises an optional adhesive layer 16, and a plurality of
optional indentations 18 on the exterior surface. The fluid
impermeable covering 14 or the substrate 12 may optionally comprise
a plurality of radiopaque markers 20. The hemostatic packing device
10 is a flat sheet that is flexible and deformable. The substrate
12 is a flat sheet configuration and is integral to or affixed to
the fluid impermeable covering 14. The fluid impermeable covering
14 optionally comprises a plurality of indentations 18. The
radiopaque markers 20 may be wire form, dots or patches of
barium-impregnated fabrics.
The substrate 12 is soft in its wet or dry state and may be bent,
molded or deformed to maximize surface contact and force
distribution on injured tissue. The substrate 12 is fabricated from
cotton gauze, open or closed cell foam, sponge, fluids,
particulates and the like, or from inflatable or packable masses of
particulates. The foam configuration of the substrate 12 may be
fabricated from materials such as polypropylene, polyvinyl
chloride, polyurethane, polyethylene, silicone rubber, poly methyl
methacrylate, polyvinyl alcohol and the like. The particulates of
the inflatable embodiment of substrate 12 may be beads of collagen,
PTFE, silica and the like. The fluid impermeable covering 14 is
fabricated from materials such as polypropylene, polyvinyl
chloride, polyurethane, polyethylene, silicone rubber, poly methyl
methacrylate, polyvinyl alcohol, Tyvsk.RTM. and the like. The fluid
impermeable covering 14 may also be fabricated from materials such
as paper or cloth that is then coated or sprayed with impermeable
materials such as polyethylene, polypropylene and the like. The use
of rip-stop fabrics will help prevent tearing of the fluid
impermeable covering 14.
The hemostatic packing device 10 is fabricated in a variety of
sizes and thicknesses. The thickness varies from 0.1 mm to 50 mm.
The length and width each may vary from 5 mm to 500 mm. The
geometry is generally rectangular but may have triangular,
circular, or polygonal configurations. The corners may be square or
rounded.
The radiopaque markers 20 are fabricated from a group of materials
including but not limited to barium impregnated fabrics or
polymers, metal wires, and metal solids. Typical metals used for
radiopacity include tantalum, platinum, gold, and the like.
The hemostatic packing device 10 is packaged in a sealed, sterile
barrier package and is sterilized using standard techniques such as
steam, cobalt radiation, ethylene oxide, electron beam and the
like.
Referring to FIG. 1B, the hemostatic packing device 10 is shown
from the side. The substrate 12, the fluid impermeable covering 14,
and the adhesive layer 16 are clearly visible in this view.
The component illustrated in FIGS. 1A and 1C are folded or rolled
to form the desired hemostatic packs, which are illustrated in
FIGS. 1C and 1D. FIG. 1C illustrates one embodiment of the
hemostatic packing device 10 that is folded with the fluid
impermeable covering 14 facing outward in preparation for use. FIG.
1D illustrates another embodiment of the hemostatic packing device
10 that is rolled with the fluid impermeable covering 14 facing
outward in preparation for use. Prior to use (either in manufacture
or in the field, immediately before packing a wound), the component
sheet is folded or rolled. If folded or rolled in manufacture, the
device will be packaged and shipped in its final form. If
manufactured in the field, the doctor or paramedic will make the
device from the component sheets, folding or rolling the sheets to
make packs of suitable size and shape, as dictated by the shape of
the wound presented.
FIG. 2 illustrates another embodiment of the haemostatic packing
device 10 where the substrate 12 and the fluid impermeable covering
14 are fabricated from the same material. In this embodiment, the
hemostatic packing device 10 is fabricated from closed-cell foam,
where the substrate is the foam, and the outer layer is the
typically impermeable skin of the foam. The foam material allows
for a resilient, deformable substrate while maintaining the fluid
impermeable covering 14 that is impermeable to fluid penetration
since it is a closed cell structure.
FIG. 3 illustrates the hemostatic packing device 10 where the upper
side of the fluid impermeable covering 14 comprises indentations
18, that may be in the form of dimpling or waffling of varying
depth that are useful to deliver thrombogenic, pharmaceutical or
antibacterial agents. The indentations 18 are formed using molds
wherein the outer surface of the fluid impermeable covering 14 of
the closed-cell substrate 12 is formed against the mold. In another
embodiment, the indents 18 are formed by impressing the fluid
impermeable outer sheet with a mold or other forming device. In yet
another embodiment, the the fluid impermeable covering 14 comprises
projections, or villi, that serve to trap and carry the
pharmaceutical, antibacterial or thrombogenic agents. The
projections or indents may be macroscopic or microscopic.
FIG. 4 illustrates another embodiment of the haemostatic packing
device 10 wherein the substrate 12 forms a polygonal solid. The
polygonal solids include shapes such as brick or rectangular solid,
waffle, pyramid, sheet, and oval. The polygonal solids also include
extruded shapes such as cylinders, or extended lengths of
cross-sections such as rectangular, oval, circular, trapezoidal,
triangular, etc. The lengths of these devices range from 5 mm to
1000 mm. The width dimensions of these devices range from 1 mm to
200 mm. For a typical use, such as v-shaped wounds such as
laceration in the leg, the device can be provided in dimensions of
about three to eight inches long (7.5 to 20 cm), with sides of
about 0.5 to 2 inches (1 to 5 cm). At least part of the fluid
impermeable covering 14 of the hemostatic packing device 10
comprises a fluid impermeable barrier. This fluid impermeable
covering 14 may be smooth, indented, or covered by villi, or
projections. The substrate 12 is fabricated from materials that
allow for deformation in the dry or wet state. These materials
include cotton batting, polymeric foams of varying densities, sand,
polymer beads, oils including silicone oils, water, and the
like.
Referring to FIGS. 1A, 1B, 1C, 1D, 2, 3, and 4, the hemostatic
packing device 10, in another embodiment, comprises a fluid fluid
impermeable covering 14 that is fabricated from resorbable
materials. The substrate 12 may be removed and the fluid
impermeable covering 14 left behind to complete healing. The 14 is
fabricated from resorbable materials such as polyglycolic acid
(PGPL), polylactic acid (PLA) and the like. The fluid impermeable
covering 14 has a complex surface that comprises indentations or
villi 18.
FIG. 5A illustrates yet another embodiment of the hemostatic,
packing device 10 wherein the device may have fluid reversibly or
irreversibly introduced to provide for size adjustment. The fluid
impermeable covering 14 is, as in the previous figures, fluid
impermeable. It is formed into a closed bladder with a shape
adapted to fill typically voids in damaged organs and body parts.
An access port 22 provides for fluid communication from the
exterior of the packing device to the interior of the device, for
introduction of substrate materials or materials to fill the
substrate 12 within the outer layer. The packs may also be filled
with water or oil, or by gas such as air, carbon dioxide, nitrogen
and the like. In this embodiment, the substrate 12 is bladder
formed from a fluid impermeable membrane that is filled with
material to achieve the desired volume. The substrate 12 membrane
is fabricated either from elastic materials such as silastic or
polyurethane, or it is an inelastic bag with folds that allow for
size increase. The outer surface of the substrate 12 preferably is
not adhered in all places to the fluid impermeable covering 14 of
said device 10 and optionally a lubricating layer 24 is placed
between the two structures. The fluid impermeable covering 14 of
said device 10 is fabricated from either elastic materials such as
polyurethane or silicone rubber, or it is an inelastic material
such as polyethylene terephthalate, polyimide, polypropylene or
polyethylene or a copolymer including one of these materials. The
fluid impermeable covering 14 of the hemostatic packing device 10
may be smooth, indented or include villi. The villi or indents may
be macroscopic and have size ranges from 0.1 mm to 10 mm. The villi
or indents may also be microscopic and difficult to see with the
unaided eye. Such sizes are less than 0.1 mm.
Referring to FIG. 5A, the hemostatic packing device 10 comprises a
hydrogel material that is placed into a wound and expands upon
absorption of fluids from the patient to compress the wound. In
this embodiment, the substrate 12 is fabricated from hydrophilic
hydrogels such as those described by Park et al. and are
incorporated herein by reference. Hydrogels are made from materials
such as, but not limited to, carboxymethyl cellulose, cross-linked
sodium starch glycolate, and cross-linked polyvinylpyrrolidone and
the like. The substrate 12 can also be fabricated from a
water-absorbable sponge that expands once it becomes wet. The
water-absorbable sponge may be fabricated from materials such as,
but not limited to polyvinyl alcohol, polymethyl cellulose, and the
like. In this embodiment, the fluid impermeable covering 14 is
provided with an opening to allow for fluid penetration into the
substrate 12 to allow the expansion to occur. This opening may be
the access port 22 and the fluid to expand the hydrogel or sponge
may be injected through the access port 22. Alternatively, in the
case of the hydrogel, the substrate 12 and the fluid impermeable
covering 14 may be of the same hydrogel material. Hydrogels
generally absorb water but do not adhere to biological surfaces.
The hemostatic packing device 10 fabricated from hydrogel would be
small enough in its dry state to be introduced through a
laparoscopic access port and expand due to water absorption once
placed within the body.
The devices of FIGS. 5A and 5B may be filled just prior to
placement in the patient. The degree to which they are filled may
be determined by the doctor or paramedic, depending on nature of
the wound, including its size and organ which is wounded. The packs
may also be filled or deflated after placement, whether to account
for leakage or to adjust the size to account for changes in
physiology or to make room for surgical devices. Such
intraoperative filling of the bladder may be accomplished in an
intraoperative time frame encompassing initial encounter and
diagnosis of the patient, field treatment, emergency treatment and
delayed treatment. The devices may also be placed peri-operatively
for a short period of recovery after surgery performed to repair
the trauma.
FIG. 6 illustrates the hemostatic packing device 10 being
introduced into a wound 42 in a liver 40 through a laparoscopic
instrument 30. The laparoscopic instrument 30 is an axially
elongate hollow device that provides porthole access to the
internal organs of a patient.
FIG. 7 illustrates the hemostatic packing device 10 comprising an
adhesive strip 28 on one side. The adhesive strip 28 is used to
permit attachment of the hemostatic packing device 10 to other
similar devices so as to create an impermeable syncytium or
impermeable contiguous mass. The adhesive strip may also comprise
an optional peel away cover that protects the adhesive strip 28
prior to use. The peel away cover is fabricated, preferably, from
the same materials use to fabricate the fluid impermeable covering
14 of the hemostatic packing device 10. The adhesive strip is
optionally fabricated from loop and hook fasteners such as
Velcro.RTM. or even self-adhesive materials such as Coban.RTM.,
marketed by 3M.
FIG. 8 illustrates another embodiment of the hemostatic packing
device 10 further comprising a fluid impermeable drape 32 affixed
to the packing device 10. The fluid impermeable drape 32 is,
preferably adhered to the hemostatic packing device 10. The drape
32 comprises an adhesive layer 36 and a backing layer 38. The
backing 38 is, preferably, fabricated from non-elastomeric
materials such as, but not limited to, polyethylene, polypropylene,
and the like. It is preferable that the drape 32 does not stretch
once applied. The adhesive layer 36 is on the same side of the
drape 32 to which the hemostatic packing device 10 is affixed. The
hemostatic packing device 10 further optionally comprises a series
of straps 34 to assist with fixation of the device to the patient.
The straps 34 are fastened with standard buckles, Velcro or the
like. This embodiment of the device 10 is useful for treatment of
wounds to the periphery and especially those wounds that involve
vascular injury. Such periphery includes the thigh, knee, lower
leg, arm, shoulder, and forearm.
FIG. 9A illustrates the wound 42 to the liver 40. The liver 40
represents an exemplary case of parenchymal tissue that is friable
and becomes severely damaged during an abdominal injury.
FIG. 9B illustrates the wound 42 to the liver 40 being treated by
application of intra-parenchemal packing using one or more
hemostatic packing devices 10. In this embodiment, two hemostatic
packing devices 10 are used to provide hemostasis for the wound 42.
The hemostatic packing devices 10 are applied manually via open
surgery or laparoscopically, depending on the nature of the wound
and the surgical technique, as determined by the doctor or
paramedic placing the packs.
FIG. 10A illustrates a wound 44 to the periphery and more
specifically, the thigh 46. The wound 44 has caused femoral artery
48 to become transected.
FIG. 10B illustrates the wound 44 to the thigh 46 being treated by
application of the impermeable hemostatic packing device 10 with
the adhesive impermeable drape 32 and straps 34.
In yet another embodiment, a wound closure is fabricated from a
material that has skin and wound contact surfaces that are
impermeable to water, blood and tissue penetration. Preferably,
these wound closure devices are fabricated from sheets of materials
such as, but not limited to, polyurethane, polypropylene,
polyethylene, silicone elastomer, and the like. The skin contact
surface is a biocompatible adhesive and is further impregnated with
anti-microbial agents such as, but not limited to, iodine, betadine
and the like. The bandage or wound closure device is large enough
to completely surround the wound and seal in the wound so that
blood cannot escape. The bandage, optionally, has additional straps
that fully surround the body or appendage and seal with Velcro,
buckles, clamps or the like. The bandage or wound closure device
seals the wound against the full systolic blood pressure and, thus
tamponade any bleeding that occurs from damaged vessels other than
the one repaired with the shunt 10. The bandage comprises an
adhesive region that sticks to the skin, even if the skin is wet or
bloody. The bandage is optionally maintained in place using straps
that wrap around the body or appendage and secure the bandage in
place with adequate pressure to generate pressure tamponade of the
wound.
The preferred wound closure is a large piece of Ioban.RTM., a
trademark and product of 3M Corporation, the non-adhesive side of
which is adhered to a piece of woven gauze or mesh to provide
adequate structure to the weak membrane of the Ioban.RTM.. The
Ioban has adhesive and anti-microbial properties preferred for this
application. A strap extending from opposing ends of the bandage
and terminated with a loop and hook fastener such as Velcro.RTM. or
3M Coban.RTM., which is self-adherent, assists in maintaining
pressure against the wound and proving full tamponade of the
hemorrhage. In yet a further embodiment, the central part of the
skin contact region comprises a malleable or conformable pad,
preferably adhered to the wound closure device, which helps to
exert hemostatic force on the wound. The conformable pad evenly
distributes the forces throughout the wound so that no areas
receive either too high a pressure, or too low a pressure, such as
would permit further bleeding. The conformable central pad may be a
block of foam covered by the aforementioned impermeable layer, or
it may be an impermeable membrane, preferably elastomeric, filled
with liquid such as saline or even a particulate material such as,
but not limited to, sand, flour, sugar, silicone oil, or the like.
In a preferred embodiment, the material used to form the
fluid-tight membrane is liquid impermeable but gas permeable.
Materials suitable for such permeability requirements include
expanded polytetrafluoroethylene (ePTFE) and the like.
FIG. 11 illustrates a wound dressing or bandage comprising a blood
dam, for treating a wound to the arm or the leg. The hemostatic
packing device 10 is in the form of a wound dressing or bandage 50.
The wound dressing or bandage 50 further comprises a gauze or
absorbent region 52. The gauze or absorbent region 52 may have
material bulked up or rolled up to aid in the application of
pressure to cause pressure tamponade of the wound or perforation to
the body. The gauze or absorbent region 52 may alternatively be a
fluid pouch, which may be inflated or deflated to apply the
required pressure tamponade to the wound area. The gauze or
absorbent region 52 is further comprised of a peripheral gasket 54
or a plurality of gaskets 54 running in a honeycomb, rectangular or
other appropriate pattern throughout and within the gauze or
absorbent region 52 of the bandage 50. The gasket 54 aids in
hemodynamic control and is made out of fluid impermeable materials,
such as, but not limited to, silicone, C-flex, hydrogels, silicone
oil-filled membrane, polyurethane closed-cell foam, and the like.
The typical width of the gasket 54 material will be 1/8 to 1/4
inch, but the gasket may be made larger for wounds that require
greater hemodynamic stabilization which can be achieved by the
damming function of a larger gasket. The gasket 54 is wide enough
to distribute pressure over the skin area so as not to cause
petcheciae, bruising or tissue damage while applying enough
pressure to seal against systemic arterial pressure, typically 100
to 300 mm Hg. The dam or gasket 54 generally presses gently into
the tissue surrounding the wound to ensure a strong resistance to
hemorrhage or leakage of blood beyond the dam. Affixed or integral
to the gauze or absorbent region 52 is a plurality of fluid
impermeable straps 58 that will wrap around the extremity or wound
area. The straps 58 may contain an adhesive layer 36 or may be of
material suitable for stretch wrapping. Optionally, the straps 58
may comprise an adhesive layer 36 and a backing layer 38. The
backing 38 is, preferably, fabricated from non-elastoineric
materials such as, but not limited to, polyethylene, polypropylene,
Tyvek.RTM., polytetrafluoroethylene, polyester, and the like.
Another option for the straps 58 could be adhesive straps 58 made
from materials such as, but not limited to, those manufactured by
3M, Inc., under the trade name of Ioban. This material would be
suitable and desirable for use as the straps 58 due to its chemical
composition and inherent antiseptic properties. In addition, the
wrapping material may also have buckles or Velcro 62 or another
means of securing or attaching the bandage in place on the patient.
Self-adhesive materials such as, but not limited to, those
manufactured by 3M, Inc., under the trade name of Coban.RTM. are
suitable for use as the binding system for the straps 58. The
straps 58 may also be fluid impermeable, so as to aid in the wound
containment. The bandage or wound dressing 50 also has a free end
or side 60. Ideally, the wound dressing or bandage 50 would be
packaged with a protective, removable layer over the gauze or
absorbent region 52 and quite possibly over the entire surface
applied to the patient.
FIG. 12 illustrates another embodiment device illustrated in FIG.
11. The hemostatic packing device 10 is in the form of a wound
dressing or bandage 50, as shown in FIG. 11. The wound dressing or
bandage 50 further comprises a gauze or absorbent region 52. The
gauze or absorbent region 52 is further comprised of a plurality of
dams or gaskets 54 running or weaving in a honeycomb, rectangular,
diamond, or other appropriate pattern throughout and within the
gauze or absorbent region 52 of the bandage 50. The gasket 54 aids
in hemodynamic control and is made out of fluid impermeable
materials, such as, but not limited to, silicone, C-flex,
hydrogels, silicone oil-filled membrane, polyurethane closed-cell
foam, and the like. The typical width of the gasket 54 material
will be 1/8 to 1/4 inch (again, the gasket may be made larger for
wounds that require greater hemodynamic stabilization which can be
achieved by the damming function of a larger gasket). The gasket 54
is wide enough to distribute pressure over the skin area so as not
to cause petcheciae, bruising or tissue damage but enough pressure
to seal against systemic arterial pressure, typically 100 to 300 mm
Hg.
FIG. 13 illustrates a wound dressing with a blood dam as shown in
FIGS. 11 and 12, modified with the addition of a valve
communication from the intended body contacting surface to the
intended exterior or superficial side of the wound dressing. The
hemostatic packing device 10 is in the form of a wound dressing or
bandage 50, similar to those shown in FIG. 11 of 12. The wound
dressing or bandage 50 further comprises a gauze or absorbent
region 52 and a valve 56. The valve 56, which resides within the
gasket 54, may be used to remove fluids or add agents to assist in
the coagulation or wound containment. The valve 56 may be, but is
not limited to, a duck bill type of valve, or the like.
FIG. 14A illustrates a system of hemostatic packs which can be
releasably attached together just prior to use to form a hemostatic
structure as desired by the doctor treating a patient. Hemostatic
packs 100 and 102 both comprise solid shapes (such as cylinders,
prisms, pyramids, cones, spheres, polyhedrons and extended lengths
with other cross-sections such as rectangular, oval, circular,
trapezoidal, triangular, etc.), each with an impermeable outer
layer 115 and a soft-conformable filler region 113. The left hand
internal pack 100 further comprises a female adhesive region 104
further comprising an adhesive material 106 and a plurality of
adhesive material gaps 108. The right hand internal pack 102
further comprises a male adhesive region 110 further comprising an
adhesive material 112 and a plurality of dams 114. In the preferred
embodiment each hemostatic pack has at least one male adhesive
region 110 and one female adhesive region 104 so that a plurality
of packs can be chained together to form a contiguous blood
impermeable barrier. In the preferred embodiment, the adhesive
material 106 is the hook style of Velcro.RTM. type hook and loop
fastener while the adhesive material 112 is the tufted style of
Velcro.RTM. fastener. Thus when the adhesive regions 106 and 112
are brought into contact, they adhere to each other. The adhesive
regions 106 and 112 are reversibly adherent to each other and may
be separated by manual force, if desired. In another embodiment,
the adhesive regions 106 and 112 may be fabricated from materials
such as 3M Coban.RTM. and the like, hydrogel adhesives and the
like, and typical adhesives such as are used in medical bandages.
Thus, the hemostatic packs are provided with releasable attachment
means, and any other suitable releasable attachment means may be
use in place of those illustrated. The adhesive material gaps 108,
in the female adhesive region 104 are spaced and designed so that
the dams 114 of the male adhesive region impinge on and seal
against an impermeable surface of the female adhesive region 104.
The adhesive material gaps 108 and the dams 114 may be configured
in a straight line or they may be curved into a wavy pattern to
improve the sealing area. Special guide markers either printed on
the packs 100 and 102 or fabricated as raised or detented surfaces
on the packs 100 and 102 facilitate alignment of the dams 114 and
the adhesive material gaps 108.
FIG. 14B illustrates a cross-sectional view of the internal packs
100 and 102 following joining to form a continuous barrier pack.
Referring to FIGS. 14A and 14B, the dams 114 seal against the
impermeable surface 115 through adhesive material gaps 108. The
adhesive regions 106 and 112 are firmly in contact and grip each
other to hold the two packs 100 and 102 together without any area
of seepage, leakage, or weeping. The dams 114 and the corresponding
receiving gaps 108 serve to block any flow of fluid through the
hook and loop fastening system (which may initially be somewhat
permeable to blood), as well as to provide guides to help doctors
assembling a gang of packs assemble them without substantial gaps
between adjacent packs. For a typical use, such as internal organ
packs (a ruptured liver, for example), the device can be provided
in dimensions of about 3 to 4 inches long, about 0.5 to 2 inches in
diameter, so that a doctor may assemble several packs into a gang
to form a substantial wall to cover a large fracture.
In yet another embodiment of the barrier pack, the mating region
between the two packs comprises adhesive regions such as those
described for FIG. 14A, except that the barrier dams are replaced
with fluid impermeable flaps that fold in to cover the adhesive
regions following joining. One flap preferably covers each side of
the adhesive region. In a preferred embodiment, the flaps cover the
adhesive regions until they are needed to join with another barrier
pack. At that time, the flap is pulled away, the two packs are
joined, and the flap is folded in to cover the adhesive region and
form a fluid-tight seal between the two barrier packs.
Referring to FIG. 1 through FIGS. 14A and 14B, the hemostatic
packing device 10 is used to treat wounds that are typically caused
by trauma. In a typical procedure, the surgeon or medic, using
aseptic procedure, accesses the wound either by open surgery or
laparoscopic surgery. The wound is irrigated and cleaned and excess
fluids are removed by suction and blotting with gauze sponges. The
surgeon may apply antiseptic agents or thrombogenic agents to the
wound. The surgeon places the hemostatic packing device 10 into the
wound and the device 10 is secured into place. Using current damage
control procedure, it is preferable to stabilize the patient prior
to removing the hemostatic packing device 10 and permanently
repairing the wound. The hemostatic packing device 10 does not
stick or heal into the wound and removal is not traumatic to the
patient. The hemostatic packing device 10 is also well suited for a
typical "sucking chest wound" because of its inherent impermeable
properties. In this use, the one-way valve 56 permits fluid and air
to exit the chest cavity but prohibits reflux of air into the chest
cavity, a condition which prevents lung function and which is known
as pneumothorax.
FIG. 15 illustrates a preferred embodiment of a wound dressing or
bandage 120. The wound dressing or bandage 120 comprises a backbone
122 with a central region and two ends, a first fastener 126, a
second fastener 128, a fluid-impermeable barrier 124, a fluid dam
132, a pillow pack 134, and an optional peripheral hemostatic
region 130. The wound dressing or bandage 120 is configured to wrap
around a body part, arm, leg, torso, head, etc. and fasten using
the first fastener 126 and the second fastener 128. The fasteners
126 and 128 are of the type including, but not limited to, Velcro,
buckles, snaps, jam cleats, buttons, and the like. An optional
cinch mechanism to increase mechanical advantage and allow the
caregiver to apply the bandage 120 with increased compression may
be added to the configuration. The backbone 122 is preferably a
woven fabric of material such as, but not limited to cotton,
polyester, polypropylene, polyurethane, polyethylene, PTFE, nylon,
and the like. The woven backbone is configured to be flexible but
have high tensile strength, while porosity is not an important
characteristic. The impermeable barrier 124 is preferably applied
to the central region of the bandage 120 and is created by a
separate polymer layer that is adhered or welded to the backbone
122. The backbone 122 may also be dipped, sprayed, or coated with
materials such as, but not limited to, polyurethane, C-Flex
thermoplastic, silicone elastomer, and the like. Since the dressing
is intended for short-term application, gas permeability is not
considered objectionable but it is desirable. The fluid dam 132 is
fabricated from materials including those used to fabricate the
fluid impermeable barrier 124. The fluid dam 132 may also be
fabricated from gel-filled membranes, hydrogels, oil-filled
membranes, and the like. The membrane of the fluid dam 132 is
preferably, inelastic at the pressures used for filling. The fluid
dam 132 is configured to provide a pressure seal against the body
and form a complete barrier to prevent blood from escaping the
wound. In another embodiment, the fluid dam 132 is inflatable
following or before application to the patient through a valve such
as a stopcock or standard inflation valve on the exterior surface
of the bandage 120.
Further referring to FIG. 15, the pillow pack 134 is adhered to the
central region of the bandage 120, preferably to the fluid
impermeable region 124. The pillow pack 134, preferably resides
within the region described by the fluid dam 132. The pillow pack
134 outer surface is preferably smooth and resistant to blood
adherence but in another embodiment, the pillow pack 134 outer
surface may be a fabric mesh or other convoluted surface capable of
accelerating thrombosis or of carrying thrombogenic materials or
antimicrobial agents. The pillow pack 134 is the primary
distributor of force upon the wound to generate pressure tamponade.
The pillow pack 134 is capable of extruding into a wound and
distributing pressure evenly to generate hemostasis. The pillow
pack 134 preferably comprises an elastomeric membrane filled with
materials such as, but not limited to, air, water, oil, sand, gel
materials, and the like. The pillow pack 134 in the embodiment
where gas, air or liquid, is used for inflation, comprises an
optional valve such as stopcock on the exterior surface of the
bandage 120. The peripheral hemostasis region 130 preferably
resides within the fluid dam 132 and accelerates clotting in the
region outside the wound area but within the environs of the
bandage 120. The peripheral hemostasis region 130 is fabricated
from materials such as, but not limited to, cotton gauze, polyester
knits and the like.
The present invention is suitable for wounds to many parts of the
body. The external hemostatic pack works on the arms, the legs, the
head, a finger, the torso, etc. The present invention also
describes a band-aid type device with the further enhancement that
a fluid-tight dam is comprised within the device to prevent blood
loss out the side of the band-aid.
The present invention includes apparatus and methods for treating
wounds. The present invention may be embodied in other specific
forms without departing from its spirit or essential
characteristics. The described embodiments are to be considered in
all respects only as illustrative and not restrictive. The scope of
the invention is therefore indicated by the appended claims rather
than the foregoing description. All changes that come within the
meaning and range of equivalency of the claims are to be embraced
within their scope.
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